HR-8528-119
Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Sponsored by Adrian Smith (R-NE)
What it does
This bill would amend Medicare's skilled nursing facility (SNF) consolidated billing rules to exclude intravenous immune globulin (IVIG) drugs used to treat primary immunodeficiency (PI) disease from the SNF prospective payment system bundle. Specifically, it would carve out nine named HCPCS drug codes — plus any future modifications designated by the Secretary — so that Medicare would reimburse these drugs separately rather than requiring SNFs to cover them within their fixed per-diem payment. The change would take effect for services furnished on or after October 1, 2026.
Who benefits
Medicare beneficiaries with primary immunodeficiency disease who require IVIG treatment while in a skilled nursing facility — a rare disease population estimated in the tens of thousands. Specialty IVIG drug manufacturers and distributors, who may see increased utilization as access barriers are reduced. Home infusion and specialty pharmacy providers that supply IVIG. SNFs that currently struggle to absorb the high cost of IVIG within their bundled payment rate. Physicians and nurses who treat PI patients in post-acute settings, who may find it easier to prescribe and administer IVIG without financial friction.
Who is hurt
Medicare's Hospital Insurance Trust Fund (Part A), which would bear the cost of separately reimbursing high-cost IVIG drugs that are currently bundled into SNF per-diem rates. Taxpayers and Medicare beneficiaries broadly, to the extent that unbundling increases total Medicare spending. Other disease groups with high-cost drugs still bundled into SNF payments, who may face comparative disadvantage or argue for similar carve-outs. SNFs that had previously negotiated favorable IVIG supply arrangements under the bundled model may lose that leverage.
Supporters argue
Supporters argue that IVIG drugs for primary immunodeficiency are extraordinarily expensive — often thousands of dollars per infusion — and that SNFs frequently cannot afford to provide them within the fixed bundled payment rate, effectively forcing PI patients to forgo post-acute care or delay necessary treatment. They contend that carving out these drugs mirrors how Medicare already handles other high-cost drugs in the SNF setting (such as certain chemotherapy agents), and that the policy would align reimbursement with clinical reality for a medically vulnerable, rare-disease population that has no therapeutic alternatives to IVIG.
Opponents argue
Opponents argue that unbundling high-cost drugs from the SNF prospective payment system undermines the core purpose of bundled payments — to incentivize SNFs to manage total care costs efficiently and reduce unnecessary utilization. They contend that creating disease-specific carve-outs sets a precedent that could erode the bundled payment model over time as other disease groups seek similar treatment, potentially increasing Medicare spending significantly. Critics may also note that the bill delegates ongoing code updates to the Secretary without clear statutory guardrails, raising questions about the scope of administrative discretion post-Loper Bright.
Constitutional context
Congress has broad authority to structure Medicare reimbursement under the Taxing and Spending Clause (Art. I, §8, cl. 1), and modifications to existing payment systems are well within established legislative practice affirmed in NFIB v. Sebelius (2012). The bill's delegation of future HCPCS code updates to the Secretary is a routine administrative function, though post-Loper Bright (2024), courts would independently assess whether any significant expansion of the carve-out by the Secretary exceeded the statutory authorization rather than deferring to the agency's interpretation.
Checks and balances
Congress gains authority to restructure Medicare SNF reimbursement; the Secretary of HHS retains delegated authority to update covered drug codes, subject to independent judicial review of any significant expansions under post-Loper Bright standards.
Historical precedent
Medicare's SNF consolidated billing rules already carve out certain high-cost drugs — including some chemotherapy agents — from the bundled payment system, establishing a direct statutory precedent for disease-specific drug exclusions.